A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
A MEDICAL GLOVE IS WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

Device Description

Latex Patient Examination glove Powderfree (blue color) Polymer coated

AI/ML Overview

Based on the provided text, the acceptance criteria and device performance for the Siam Sempermed D Corporation's Latex Patient Examination Glove Powderfree are as follows:

1. Acceptance Criteria and Reported Device Performance

Description	Acceptance Criteria (ASTM Standard / Specification)	Reported Device Performance
DIMENSION	S-2 AQL 4.0	S-2 AQL 4.0
Overall length	230 mm MIN.	240 +/- 10 mm
Width (double wall)	S 80 +/- 10 mm; M 95 +/- 10 mm; L 111 +/- 10 mm	SS ≤ 80 mm; S 83 +/- 5 mm; M 94 +/- 5 mm; L 105 +/- 4 mm; XL 110 +/- 5 mm
Thickness, mm
Finger	0.08 mm MIN.	0.08 mm MIN.
Palm	0.08 mm MIN.	0.08 mm MIN.
PHYSICAL PROPERTIES	S-2 AQL 4.0	S-2 AQL 4.0
Before Aging Tensile strength	According to ASTM D3578-95	14 Mpa MIN.
Before Aging Elongation at break	According to ASTM D3578-95	700% MIN.
After Aging Tensile strength		14 Mpa MIN.
After Aging Elongation at break		500% MIN.
WATER EXTRACTABLE PROTEIN	N/A	S-2 AQL 4.0
POWDER LEVEL	N/A	2 mg MAX.
FREEDOM FROM HOLE	S-4 AQL 4.0	II AQL 1.5

The document states: "Siam Sempermed Latex Patient Examination Glove Powderfree (blue color) polymer coated meet the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims". This indicates that the reported device performance meets or exceeds all the specified acceptance criteria.

2. Sample size used for the test set and the data provenance

The document specifies "S-2 AQL 4.0" for dimensions and physical properties, "S-4 AQL 4.0" for freedom from hole, and "II AQL 1.5" for freedom from hole. AQL (Acceptable Quality Limit) refers to an inspection level and a sampling plan, but the exact sample size (n) for the test set is not explicitly stated in the provided text. The data provenance is from Siam Sempermed D Corporation, Ltd in Thailand, and the study appears to be prospective manufacturing quality testing to ensure the product meets specified standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. The evaluation criteria are based on objective physical and chemical properties and ASTM standards, which typically do not involve expert consensus in the same way medical imaging or diagnostic devices might.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the context of this device. The assessment is based on measured physical and chemical properties against established standards, not on subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed or is relevant for this device. This is a medical glove, a Class I device, and its performance is evaluated based on physical characteristics and material properties, not on diagnostic performance aided by AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No standalone algorithm-only performance testing was done or is relevant for this device. This device is a physical product (a glove), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is based on objective measurements against established engineering and material standards, specifically ASTM D3578-95 and internal specifications for dimensions, physical properties, water extractable protein, powder level, and freedom from holes. For "Freedom from Hole," it also refers to "pinhole FDA requirements."

8. The sample size for the training set

There is no "training set" in the context of this device. It is not an AI/ML or diagnostic device that requires training. The described process is a quality control and conformity assessment against manufacturing standards.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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Siam Sempermed D Corporation , Ltd

510(k) SUMMARY 01.11.1997

NOV 20 1998

· 0 APPLICANT:

Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION. Ltd. 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: 66 074 291 648 OR 291 649 FAX: 66 074 291 650

2.0 CONTACT PERSON

Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION.,Ltd 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: 66 074 291 648 OR 291 649 FAX: 66 074 291 650

MR DON MORRIS SATARI CORP.,Ltd 30798 US Hwy 19 N Palm Harbor USA FL 34684 TEL: 813 787 7250 OR 800 366 9545 FAX: 813 787 7558

3.0 Device Class: I Product code: 80LYY
4.0 Specification: Latex patient examination glove powderfree -Class I 80LYY meets all of the requirements of ASTM standard D3578-95
5.0 Device Description: Latex Patient Examination glove Powderfree (blue color) Polymer coated
6.0 Intended use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
7.0 Surface treatment: Polymer coated, Halogenation/Siliconization and extensive washing in water Outer surface: Free from glove powder

as document and its contents are confidential. Do not discuss with or give access to people not designated.

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510(k) SUMMARY 01.11.1997

~ 9 QUALITY CHARACTERISTICS

DESCRIPTION	ASTM standard	SPECIFICATION
DIMENSION	S-2 AQL 4.0	S-2 AQL 4.0
Overall length	230 min.	240+/-10 mm
Width(double wall)	S 80 +/- 10 mmM 95 +/- 10 mmL 111 +/- 10 mm	SS ≤ 80 mmS 83 +/- 5 mmM 94 +/- 5 mmL 105 +/- 4 mmXL 110 +/- 5 mm
Thickness, mm
Finger	0.08 mm MIN.	0.08 mm MIN.
palm	0.08 mm MIN.	0.08 mm MIN.
PHYSICAL PROPERTIES	S -2 AQL 4.0	S-2 AQL 4.0
Before and agingTensile strengthElongation at break	According toASTM D3578-95	14 Mpa MIN700% MIN.
After agingTensile strengthElongation at break		14 Mpa MIN.500% MIN.
WATER EXTRACTABLEPROTEIN	N/A	S-2 AQL 4.0
POWDER LEVEL	N/A	2 mg MAX.
FREEDOM FROM HOLE	S-4 AQL 4.0	II AQL 1.5

9.0 Conclusion: Siam Sempermed Latex Patient Examination Glove Powderfree (blue color) polymer coated meet the ASTM standard or equivalent standard meet pinhole FDA requirements

meet labeling claims (see 5.0 and 6.0 above)

Pousank

Dr. POONSUK CHERDKIATGUMCHAI Corporate Officer (quality)

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all black, and they are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Nov 20 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SIAM SEMPERMED CORPORATION, Limited C/O Mr. Don Morris SATARI Corporation, Limited 30798 US Hiqhway 19N Palm Harbor, Florida 34684

K981975 Re : Latex Patient Examination Glove Powder-Free Trade Name: (Blue Color) Polymer Coated Requlatory Class: I Product Code: LYY October 20, 1998 Dated: October 21, 1998 Received:

Dear Mr. Morris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Morris

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timoth A. Ulat Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN) : __ K981975

DEVICE NAME: LATEX PATIENT EXAMINATION GLOVE -POWDER FREE POLYMER COATED - BLUE INDICATIONS FOR USE:

A MEDICAL GLOVE IS WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter-Use X
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K98 1975

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.